drugset / Trial / NCT07646821
A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in Newly Diagnosed MDS/AML (≥ 10% Blasts) With TP53 Mutations
Non-randomizedSingle-groupOpen-labelTreatment
Summary
To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS/AML with TP53 mutations. To learn if the recommended dose of ropeinterferon alfa-2b found in Dose Escalation in combination with azacitidine can help to control the disease.
Timeline
- Start
- 2026-11-27
- Primary completion
- 2028-12-11
- Completion
- 2030-12-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ropeginterferon alfa-2b | Protein / enzyme biologic | — | Intravenous |
| Background | Azacitidine | Other / unclassified | — | Intravenous |